Status:
COMPLETED
Dose-Finding Study of CD07805/47 Topical Gel in Subjects With Erythematotelangiectatic Rosacea
Lead Sponsor:
Galderma R&D
Conditions:
Erythematotelangiectatic Rosacea
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, ...
Eligibility Criteria
Inclusion
- Male or female who is at least 18 years of age.
- Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
- CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
- PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
- Presence of 2 or fewer inflammatory facial lesions.
Exclusion
- History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
- History of refractive surgery such as photorefractive keratectomy.
- The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
- The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00989014
Start Date
September 1 2009
End Date
December 1 2009
Last Update
February 18 2021
Active Locations (5)
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1
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
2
Philadephia Institute of Dermatology
Fort Washington, Pennsylvania, United States, 19034
3
Derm Research, Inc
Austin, Texas, United States, 78759
4
J&S Studies
College Station, Texas, United States, 77845